ANDA 091344

PERRIGO ISRAEL

FDA Drug Application

Application #091344

Documents

• Letter: 2011-05-03

Application Sponsors

ANDA 091344

PERRIGO ISRAEL

Marketing Status

• Over-the-counter: 001

Application Products

001

AEROSOL, FOAM;TOPICAL

5%

0

MINOXIDIL

MINOXIDIL

FDA Submissions

	ORIG	1	AP	2011-04-28
LABELING; Labeling	SUPPL	14	AP	2016-11-13	STANDARD
LABELING; Labeling	SUPPL	16	AP	2017-03-03	STANDARD
LABELING; Labeling	SUPPL	20	AP	2020-06-10	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	14	Null	7
SUPPL	16	Null	7
SUPPL	20	Null	7

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91344
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MINOXIDIL","activeIngredients":"MINOXIDIL","strength":"5%","dosageForm":"AEROSOL, FOAM;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MINOXIDIL","submission":"MINOXIDIL","actionType":"5%","submissionClassification":"AEROSOL, FOAM;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)